HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

Overview

Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission. The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation. This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.

Full Title of Study: “A Randomized,Double-Blind , Placebo-Controlled Crossover Trial of Antivirals for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Co-infected Persons”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2005

Detailed Description

Conducted in Lima Peru, 20 HIV-1 and HSV-2 seropositive women with CD4 counts greater than 200 and on no antiretroviral therapy were randomly assigned to receive valacyclovir 500 mg bid or placebo for the first 8 weeks of the study. After these 8 weeks, a 2-week washout period followed, which was then followed by the alternative regimen for 8 weeks.

Interventions

  • Drug: Valacyclovir
    • 500mg oral twice daily
  • Drug: Matching Placebo
    • 500 mg oral twice daily

Arms, Groups and Cohorts

  • Experimental: I

Clinical Trial Outcome Measures

Primary Measures

  • Plasma HIV-1 levels and HIV-1 mucosal shedding
    • Time Frame: 18 weeks

Secondary Measures

  • Mucosal HSV-2 shedding
    • Time Frame: 18 weeks
  • Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation;
    • Time Frame: 18 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Greater than 18 years old woman, – Documented HIV-1 seropositive, – CD4 count greater than 200, – Not on HIV antiretroviral therapy, – HSV-2 seropositive as determined by Focus EIA (IN >3.5) – Not intending to move out of the area for the duration of study participation. – Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule. – Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment. Exclusion Criteria:

Women who meet any of the following criteria are not eligible for this study:

  • Known history of adverse reaction to valacyclovir, acyclovir or famciclovir; – Planned open label use of acyclovir, valacyclovir, or famciclovir – Known medical history of seizures – Known renal failure, serum creatinine >2.0mg/dl – Hematocrit < 30 %

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Connie Celum MD MPH, University of Washington
  • Overall Official(s)
    • Connie Celum, MD, MPH, Principal Investigator, University of Washington

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